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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06047717
Other study ID # 00008669
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 28, 2023
Est. completion date October 2026

Study information

Verified date December 2023
Source University of Rochester
Contact Chrys Callan
Phone 585-276-3426
Email Christine_Callan@URMC.Rochester.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to better understand the impact of cortically-induced blindness (CB) and the compensatory strategies subjects with this condition may develop on naturalistic behaviors, specifically, driving. Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments. Through the combined use of computer vision, deep learning, and gaze-contingent manipulations of the visual field, this work will test the central hypothesis that changes to visually guided steering behaviors in CB are a consequence of changes to the visual sampling and processing of task-related motion information (i.e., optic flow).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility Cortically Blind Group: Inclusion Criteria: - Residents of the United States or Canada - Presence of one-sided stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans) - Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey or equivalent perimetry. - Willing, able, and competent to provide their own informed consent - Cognitively able, responsible to understand written and oral instructions in English - Emmetropic or else wear corrective contact lenses inside the virtual reality headset Exclusion Criteria: - Those who have never driven or earned a drivers' license - Past or present ocular disease interfering with visual acuity - Best corrected visual acuity (BCVA) worse than 20/40 in either eye - Sustained damage to the dorsal lateral geniculate nucleus - Presence of diffuse, whole-brain degenerative processes - Presence of brain damage deemed by study staff to potentially interfere with outcome measures - History of traumatic brain injury - Documented history of drug/alcohol abuse - Diagnosis of cognitive or seizure disorders - Diagnosis of one-sided attentional neglect Control Group: Inclusion Criteria: - Normal or corrected-to-normal vision, who are between the ages of 21 and 75 years of age, roughly matched to the age of CB subjects enrolled above - Competent and responsible, as determined by the Principal Investigator - Willing, able, and competent to provide their own informed consent - Normal cognitive abilities, be able to understand written and oral instructions in English - Emmetropic or else wear corrective contact lenses inside the virtual reality headset Exclusion Criteria: - Subjects who have never driven or earned a drivers' license - BCVA worse than 20/40 in either eye - Presence of vision loss from ocular diseases or disorders - Presence of a visual field defect - Inability to wear corrective contact lenses inside the virtual reality helmet if required to see clearly - Subjects with a history of neurological disorders - Subjects with a history of TBI - Persons who lack the competence or are otherwise unable to perform the visual testing as directed.

Study Design


Intervention

Other:
Virtual Reality Driving Task
Participants will steer a virtual car with the goal of staying in the center of a single-lane roadway while traveling at a constant speed of 26.6 m/s (approximately 60 miles/hr). The roadway alternates between a series of straights and turns of different radii to both the left and the right. This allows for careful control of task difficulty, and for the repeated presentation of specific conditions across multiple "trials" (i.e. turns in the road) in a randomized order. In addition, the density of the visual texture elements in the virtual environment that provide optic flow (OF) signal is also varied. The low-density OF condition has no road texture or foliage, and only the solid road edges on a flat-black ground plane. The medium-density OF condition has sparse textural elements distributed on the ground plane, and the high-density OF condition has high density road texture and a canopy of road-side trees that provide texture extending far above the horizon.

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Rochester Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Virtual Reality (VR) Lane Deviation / Offset Virtual lane offset is a measure of driving accuracy, which involves computing the divergence (in virtual meters) from the center of the single-lane virtual roadway, relative to the position of the driver's head and averaged over the duration of each turn. The researchers will compare the variance of lane offset in virtual meters between Cortically Blind (CB) and control subjects. Day 0
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